[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658615":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":35,"armGroups":43,"interventions":56,"overallOfficials":35,"centralContacts":64,"locations":70,"responsibleParty":90,"collaborators":35,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":35,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":35,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":35,"overallStatus":72,"whyStopped":35,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Stone-free rate","Stone-free rate will be assessed at 4 weeks postoperatively using non-contrast computed tomography (CT). It will be defined as the absence of residual stones or the presence of clinically insignificant residual fragments (asymptomatic, non-obstructive fragments 2:3mm).","4 weeks postoperatively",[14,17,21,24,28,31],{"measure":15,"description":16,"timeFrame":12},"Incidence of complication","Incidence of complication will be assessed using ClavienDindo classification. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed treatments include antiemetics, antipyretics, analgesics, diuretics, electrolytes, physiotherapy, and opening wound infections at the bedside.\n\nGrade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I complications. Blood transfusions and total parenteral nutrition (TPN) are also included in this grade.\n\nGrade III: Requiring surgical, endoscopic, or radiological intervention. Grade IV: Life-threatening complication (including central nervous system complications) requiring intermediate Grade V: Death of the patient.",{"measure":18,"description":19,"timeFrame":20},"Operative time","Operative time will be recorded from start of the surgery till the end of surgery.","Intraoperatively",{"measure":22,"description":23,"timeFrame":20},"Fluoroscopy time","Total fluoroscopy time during the procedure will be measured.",{"measure":25,"description":26,"timeFrame":27},"Hemoglobin drop","Difference in hemoglobin level between the preoperative and postoperative measurements will be recorded.","24 hours after the procedure",{"measure":29,"description":30,"timeFrame":27},"Need for blood transfusion","Requirement for blood transfusion during the perioperative period will be recorded",{"measure":32,"description":33,"timeFrame":34},"Length of hospital stay","Length of hospital stay will be recorded from admission till discharge from hospital.","Till discharge from hospital (Up to 2 weeks)",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE","The choice between papillary and non-papillary access during percutaneous nephrolithotomy (PCNL) continues to influence procedural outcomes and surgical preferences. The papillary Access puncture, which targets the tip of the renal pyramid, aligns with the natural flow of the collecting system and is traditionally associated with minimal bleeding and parenchymal damage, thus being considered the standard approach in PCNL. It allows optimal tract dilation and access to stones with reduced complication rates when performed correctly.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Group A","ACTIVE_COMPARATOR","Patients will undergo papillary access puncture (Control group)",[49],"Procedure: Papillary access puncture",{"label":51,"type":52,"description":53,"interventionNames":54},"Group B","EXPERIMENTAL","Patients will undergo non-papillary access puncture",[55],"Procedure: Non-papillary access puncture",[57,61],{"type":58,"name":59,"description":47,"armGroupLabels":60,"otherNames":35},"PROCEDURE","Papillary access puncture",[45],{"type":58,"name":62,"description":53,"armGroupLabels":63,"otherNames":35},"Non-papillary access puncture",[51],[65],{"name":66,"role":67,"phone":68,"phoneExt":35,"email":69},"Mohamed I El-Sayed, MBBCH","CONTACT","00201068569307","29709041800133@med.asu.edu.eg",[71],{"facility":5,"status":72,"city":73,"state":35,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Cairo","11591","Egypt","EG",{"type":78,"coordinates":79},"Point",[80,81],31.24967,30.06263,{"lat":81,"lon":80},[84,85,88],{"name":66,"role":67,"phone":68,"phoneExt":35,"email":69},{"name":86,"role":87,"phone":35,"phoneExt":35,"email":35},"Mohamed K Tolba, MD","SUB_INVESTIGATOR",{"name":89,"role":87,"phone":35,"phoneExt":35,"email":35},"Mohamed S Salim, MD",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Mohamed Ibrahem","Resident of Urology, Faculty of Medicine, Ain Shams University, Cairo, Egypt","100658615","safety-and-efficacy-of-papillary-versus-nonpapillary-access-during-percutaneous-nephrolithotomy-100658615",false,"NCT07855354","Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy","Evaluation of Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy: A Prospective Randomized Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Solitary or multiple renal calculi ≥2 cm\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Bleeding diathesis or uncorrected coagulopathy\n* Active urinary tract infection at the time of surgery\n* Congenital anomalies severely distorting renal anatomy (e.g., horseshoe kidney, ectopic kidney)\n* Morbid obesity \\[body mass index (BMI) ≥ 40\\] limiting safe positioning\n* Pregnancy","ALL","18 Years",{"count":104,"type":105},70,"ESTIMATED","INTERVENTIONAL",[108],"NA","This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in selected patients.",[111,112,113,114,115],"Safety","Efficacy","Papillary","NonPapillary","Percutaneous Nephrolithotomy","2026-09-28",{"date":118,"type":119},"2026-10-02","ACTUAL",{"date":121,"type":119},"2025-11-01",{"date":123,"type":105},"2026-10-30",{"name":5,"class":6},1]